ID 2618 - Olej z kiełków pszenicy

PL: Olej z kiełków pszenicy
EN: Wheat (Triticum vulgare) - wheat germ oil
Pdf: wheat germ oil

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food that is the subject of the health claims is wheat germ oil.
In the context of the references provided (Alessandri et al., 2006; Kahlon, 1989; Ostlund et al., 2003), the Panel assumes that wheat germ oil is extracted from the germ of the wheat kernel, that is rich in n-6 fatty acids, mainly linoleic acid (~60 %), and that also contains oleic acid (~10-12 %), alpha- linolenic acid (~7-9 %) and saturated fatty acids (~20 %), mainly palmitic acid. Wheat germ oil also contains vitamin E (~150 mg/100 g), octacosanol (a very-long-chain fatty alcohol present in plant waxes), phytosterols (~550 mg/100 g), vitamin K (~ 25 μg/100 g) and choline (~20 mg/100 g).
The Panel notes that wheat germ oil contains about 60 % of linoleic acid (LA) and 7-9 % alpha- linolenic acid (ALA). Claims on LA and on ALA, both related to the maintenance of normal cholesterol concentrations in the context of article 13 claims under Regulation (EC) 1924/2006 have already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009a,b). Therefore the Panel will address in the present opinion whether consumption of wheat germ oil has an effect on blood cholesterol concentrations beyond what could be expected from its content in LA and ALA.
The Panel considers that the food, wheat germ oil, which is the subject of the health claims is sufficiently characterised.

2.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 599, 2618)

The claimed effects are “cholesterol” and “decreases cholesterol and triglycerides levels, wheat germ oil is an omega 3 source”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claim refers to the maintenance of normal blood cholesterol concentrations.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries. Elevated LDL-cholesterol, by convention >160 mg/dL (>4.14 mmol/L), may compromise the normal structure and function of the arteries. High-density lipoproteins (HDL) act as cholesterol scavengers and are involved in the reverse transport of cholesterol in the body (from peripheral tissues back to the liver).
The Panel considers that maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.

2.3. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 2618)

The claimed effect is “decreases cholesterol and triglycerides levels, wheat germ oil is an omega 3 source”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance of normal blood concentrations of triglycerides.
Triglycerides in plasma are either derived from dietary fats or synthesised in the body from other energy sources like carbohydrates. In fasting conditions, serum triglycerides are mainly transported in very-low-density lipoproteins (VLDL) synthesised in the liver. Excess energy intake with a meal is converted to triglyceride and transported to the adipose tissue for storage. Hormones regulate the release of triglycerides from adipose tissue in order to meet energy needs between meals. Normal values for blood concentrations of triglycerides have been defined.
The Panel considers that maintenance of normal (fasting) blood concentrations of triglycerides may be a beneficial physiological effect.

3.2. Utrzymanie prawidłowego stężenia cholesterolu we krwi (ID 599, 2618)

Most of the references provided for the scientific substantiation of the claim reported on foods other than wheat germ oil (wheat germ, sterols/stanols, wheat bran). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
One randomised double-blind parallel intervention in humans on the effects of wheat germ oil on blood lipids was provided (Alessandri et al., 2006). A total of 32 hypercholesterolaemic men and
women were randomly allocated to consume one tablespoon per day of either maize oil or wheat germ oil for two months. The oils differed inter alia in the amount of alpha-linolenic acid, with 0.63 % in maize oil vs. 8.6 % in wheat germ oil. No significant changes in the blood lipid profile were observed between groups during the study.
The Panel concludes that a cause and effect relationship has not been established between the consumption of wheat germ oil and maintenance of normal blood cholesterol concentrations beyond the hypocholesterolaemic effects that could be expected from its fatty acid composition (e.g. primarily from its content of linoleic acid and alpha-linolenic acid).
Claims on linoleic acid and on alpha-linolenic acid and maintenance of blood cholesterol concentrations have been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009a,b).

3.3. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 2618)

Most of the references provided for the scientific substantiation of the claim reported on foods other than wheat germ oil (wheat germ, sterols/stanols, wheat bran). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
One randomised double-blind parallel intervention in humans already described in section 3.2 was provided (Alessandri et al., 2006). No significant changes in blood lipids were observed between the intervention and control groups during the study.
The Panel concludes that a cause and effect relationship has not been established between the consumption of wheat germ oil and maintenance of normal (fasting) blood concentrations of triglycerides.

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